Investigational Product Packaging: Documentation & Handling for Clinical Trials

Investigational products are pharmaceutical ingredients used in clinical trials. The ingredients may be active or placebos. Regardless, the sample packaging of investigational products must properly documented, shipped, received and dispensed to pharmacists and healthcare facilities that participate in clinical trials. The protocol for packaging and preparing investigational products ensures that the clinical drugs are administered in a methodical and effective manner.

Things You'll Need

• Labels
• Instructions
• Pill bottles and packages

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Instructions

• 1

  Prepare the sample amount as indicated by the pharmacist and dispense it into the appropriate-sized bottles or cartons.

• 2

  Type the clinical name of the trial drug or ingredient on the packaging.

• 3

  Type the dosage amount of the ingredient; document the dosage instructions for the drug.

• 4

  Provide instructions to the pharmacist with regards to dispensing, handling and storing the drug. Pharmacists are required to store the drug in a safe, secure manner. If the drug needs to be at a particular room temperature, indicate the necessary temperature on the label.

• 5

  Print the label instructions on an adhesive label and securely fasten it to the drug sample container. Apply the label over the ingredient name to mask whether it is an active or placebo ingredient.